Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion Tool, product code iBIT-1.
Recall
- Recall Number
- Z-0409-2010
- Event Number
- 53694
- Firm
- Surgical Devices/Covidien
- FEI Number
- 1219930
- Product Code
- GDW
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 23, 2009
- Posted
- November 23, 2009
- Terminated
- March 8, 2010
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908
Description
Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion Tool, product code iBIT-1.
Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.
The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.
3427 units